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The company is voluntarily recalling the products because of potential contamination with Burkholderia cepacia.
On August 22, 2017, Centurion Labs announced it was voluntarily recalling one lot of Ninjacof and one lot of Ninjacof A to the retail level because of the potential for Burkholderia cepacia (B. cepacia) contamination. The recall is a precautionary measure taken after the company was notified by FDA that the product may have been manufactured in a facility that had product contaminated by B. cepacia.
Ninjacof and Ninjacof A are used to treat symptoms of the common cold, allergic rhinitis, or other respiratory allergies. Patients with compromised immune systems or chronic lung conditions who use product contaminated by B. cepacia could develop infections, according to the company. As of the August 22, Centurion Labs has not found B. cepacia in product nor has it received any customer complaints.
The affected product was manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs. The recalled lots, Ninjacof Lot# 200N1601 (NDC 23359-032-16) and Ninjacof A with Lot# 201NA1601 (NDC 23359-033-16), were distributed in Alabama, Arkansas, Florida, Georgia, Louisiana, Missouri, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Tennessee, and Texas.
The company is recommending that patients, pharmacies, and healthcare facilities stop use of the product immediately. Adverse events can be reported to FDA via its website.